Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
1 other identifier
observational
76
1 country
34
Brief Summary
Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning. However, there are still some patients with only persistent clinical manifestations of chest tightness. Concerned about this group of patients, we presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time. In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA. Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedOctober 27, 2020
October 1, 2020
4.8 years
July 24, 2017
October 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Asthma control questionnaire (ACQ)
Asthma control questionnaire (ACQ)
Change from Baseline ACQ score at 36 months
Secondary Outcomes (6)
Forced expiratory volume in one second
Change from Baseline ACQ score at 36 months
Airway responsiveness
Change from Baseline ACQ score at 36 months
Peak expiratory flow
Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire
Change from Baseline ACQ score at 36 months
Acute asthma episode
Change from Baseline ACQ score at 36 months
- +1 more secondary outcomes
Interventions
Treat patient according to Global Initiative for Asthma (GINA) guideline
Eligibility Criteria
Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
You may qualify if:
- all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
- the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
- the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
- no wheezing;
- a diagnosis of asthma supported by one or more other characteristics:
- bronchial provocation test positive;
- improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;
- variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.
- bronchodilator and glucocorticoid treatment is effective;
- exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.
You may not qualify if:
- can not cooperate with related inspection or for other reasons;
- patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);
- history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;
- taking part in other drug clinical trial project, or drop out less than 3 months;
- during pregnancy, lactation women;
- obvious abnormal of High Resolution CT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital，Third Military Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital，Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, China
People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Affiliated Hospital,Zhanjiang Medical College
Zhanjiang, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Central Hospital of Shenyang Military
Shenyang, Liaoning, China
The First Affiliated Hospital, China Medical University
Shenyang, Liaoning, China
Xijing Hospital
Xi'an, Shaanxi, China
Qilu Hospital, Shandong University
Jinan, Shandong, China
Shandong Provincal Hospital
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Weifang Asthma Hospital
Weifang, Shandong, China
Yantai liuhuanding Hospital
Yantai, Shandong, China
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
No.1 Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Xinhua Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, 310000, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
The Second Affiliated Hospital,Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huahao Shen
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director，Respiratory and Critical Care Medicine，Clinical Vice Professor
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 2, 2017
Study Start
March 1, 2015
Primary Completion
December 12, 2019
Study Completion
October 23, 2020
Last Updated
October 27, 2020
Record last verified: 2020-10